EpiphaniQ for Injection (79813-301)

Manufacturer: EpiphaniQ LLC
Effective date: 2021-12-29
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 02:15:26

Label at a glance#

ProductEpiphaniQ

Active ingredientZINC IODIDE

Label structure2 sections

Dosage and administration

For Intravenous Infusion Only Single-dose vial Each vial contains Zincum Iodatum----100mg Reconstitution needed. Use one vial for 500ml saline water for IV

Label contents#

Full prescribing information#

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

For Intravenous Infusion Only
Single-dose vial

Each vial contains
Zincum Iodatum----100mg

Reconstitution needed.
Use one vial for 500ml saline water for IV

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_EpiphaniQ_IV_10mL_vial

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79813-301-11	2022-07-29	C162847	48780-1	e4f33bdf-aec9-d8a0-e053-dadaa90a6e4e	EpiphaniQ for Injection (79813-301)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79813-301-11	EpiphaniQ	10 mL in 1 VIAL	INJECTION, SOLUTION, CONCENTRATE	10		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79813-301	EPIPHANIQ (ZINCUM IODATUM) INJECTION, SOLUTION, CONCENTRATE [EPIPHANIQ LLC]	5	Legacy NDC, 1 package rows	20211230_a359a254-19dd-410e-b480-34dfdbf0960a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

EpiphaniQ
Zincum Iodatum
DIMETHYL SULFOXIDE
WATER
ZINC IODIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
79813-301	79813-301-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIMETHYL SULFOXIDE	YOW8V9698H	IACT
WATER	059QF0KO0R	IACT
ZINC IODIDE	762R7A0O0B	ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d44e8073-d8ec-7c76-e053-2995a90a3e42			a359a254-19dd-410e-b480-34dfdbf0960a	2021-12-29		Exact identifier spl id: d44e8073-d8ec-7c76-e053-2995a90a3e42 spl set id: a359a254-19dd-410e-b480-34dfdbf0960a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.